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VivoSim Platform Predicts Gastrointestinal Toxicity (Diarrhea) in an AI Model Trained on Human Intestinal Model Results – Without Animal Testing

(Neutral)
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AI

VivoSim (Nasdaq: VIVS) announced an AI prediction tool, VitroSense™, trained on data from its NAMkind™ ileum and colon 3D human intestinal models to predict drug-induced diarrhea. VivoSim reports the model attained 96% predictive accuracy using a training set of dozens of compounds. The platform supports oral and IV dosing simulations and detected differential effects from antibody-drug conjugates (ADCs). NAMkind™ liver and small-intestine services are offered in the US, Europe, Korea, and China as the company scales capacity.

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Positive

  • 96% predictive accuracy for diarrhea risk
  • Human 3D NAM models (ileum and colon) used to train AI
  • Supports oral and IV administration simulations for testing
  • ADC-specific detection of epithelial and payload effects
  • Services available in US, Europe, Korea, China

Negative

  • Model trained on a relatively limited set: dozens of compounds
  • No publicly reported independent validation or peer-reviewed dataset
  • Claims of transformational impact presented as company belief rather than validated outcome

News Market Reaction – VIVS

-0.67% 2.9x vol
5 alerts
-0.67% Session close to close
+5.1% Peak Tracked
-14.4% Trough Tracked
$4.36M Market Cap
2.9x Rel. Volume

In the Apr 28 session, VIVS declined 0.67%, reflecting a mild negative market reaction. Argus tracked a peak move of +5.1% during that session. Argus tracked a trough of -14.4% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. Trading volume was elevated at 2.9x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights VivoSim’s integration of NAMkind™ intestinal models with AI, achieving ...
Analysis

This announcement highlights VivoSim’s integration of NAMkind™ intestinal models with AI, achieving 96% predictive accuracy for diarrhea risk using human-based assay data. It builds on earlier ADC toxicity-validation updates and global NAMkind™ rollout. Regulatory filings, however, show modest quarterly revenue of about $26,000, significant net losses, and a large accumulated deficit of $350.2 million. Key metrics to watch include revenue growth from AI‑enabled NAM services and future capital-raising activity.

Key Figures

AI diarrhea prediction accuracy: 96% Quarterly revenue: $26,000 Quarterly net loss: $2.7 million +5 more
8 metrics
AI diarrhea prediction accuracy 96% VitroSense model trained on NAMkind™ intestinal assay data
Quarterly revenue $26,000 Quarter ended December 31, 2025 (all royalty income)
Quarterly net loss $2.7 million Quarter ended December 31, 2025
Nine‑month net loss $8.1 million First nine months of fiscal 2026
Cash and equivalents $4.3 million Balance at December 31, 2025
Operating cash outflow $8.6 million Negative operating cash flow between March 31 and December 31, 2025
Public offering size $4,000,000 Best-efforts public offering registered in S-1/S-1A
Accumulated deficit $350.2 million As disclosed in S-1 registration statement

Historical Context

5 past events · Latest: Apr 01 (Negative)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 01 Equity offering Negative +13.3% Best-efforts public offering of up to $4.0M with warrants and two tranches.
Mar 24 ADC toxicity data Positive -2.4% NAMkind™ liver and intestine models validated for ADC toxicity prediction versus clinical outcomes.
Mar 03 Leadership hire Positive -12.7% Appointment of VP Global Sales to drive commercial expansion of liver and GI NAM services.
Feb 11 Conference data Positive +0.0% Planned presentation of NAMkind™ ADC validation data at Society of Toxicology meeting.
Jan 29 Distribution deal Positive +71.8% New distributors in Korea and China expand Asia-Pacific access to NAMkind™ services.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent VIVS news often showed divergence: positive operating updates sometimes saw flat or negative moves, while a dilutive offering saw a positive reaction.

Recent Company History

Over the last few months, VIVS has combined commercial expansion with financing moves. On Jan 29, it expanded Asia-Pacific distribution for NAMkind™ services, coinciding with a strong positive price move. Subsequent news on ADC validation and a new VP of Global Sales in March were operationally positive but met with muted or negative reactions. An early April offering of up to $4 million then drew a positive response. Today’s AI-based intestinal toxicity prediction tool builds directly on March ADC and intestine model validation themes.

Key Terms

gastrointestinal toxicity, intestinal epithelial integrity, machine‑learning analytics, intestinal epithelium, +3 more
7 terms
gastrointestinal toxicity medical
"VivoSim Platform Predicts Gastrointestinal Toxicity (Diarrhea) in an AI Model..."
Damage or harmful side effects that a drug, medical treatment, or chemical causes to the digestive system — including the stomach, intestines, liver and related organs — which can show up as nausea, diarrhea, bleeding or inflammation. Investors care because these effects can slow or stop drug approvals, require expensive additional testing or warning labels, reduce how many patients can use a product and raise legal or manufacturing costs, all of which can materially affect a company’s value.
intestinal epithelial integrity medical
"identify drug‑induced disruptions to intestinal epithelial integrity and function."
The state of the gut lining being intact and working properly so it controls what passes from the intestines into the bloodstream; think of it as a selective wall or sieve that lets nutrients through but keeps harmful substances out. Investors care because loss of this integrity is linked to disease, treatment opportunities, regulatory milestones and healthcare costs, so therapies, diagnostics or products that restore or measure it can affect a company’s market size and valuation.
machine‑learning analytics technical
"integrates its proprietary NAMkind™ ileum and colon tissues with advanced machine‑learning analytics"
Machine‑learning analytics uses computer programs that learn from data to spot patterns, make predictions, and automate decisions—like a smart assistant that gets better the more examples it sees. For investors, it matters because these tools can improve forecasting, speed up operations, and uncover risks or opportunities that humans might miss, potentially affecting a company’s growth, costs and competitive edge.
intestinal epithelium medical
"effective screen for effects on the intestinal epithelium for oncology ADC candidates."
A continuous layer of cells that lines the inside surface of the small and large intestines, acting like an internal skin that absorbs nutrients and keeps harmful substances out. Investors should care because this tissue determines how well oral drugs are absorbed, how digestive diseases develop and respond to treatment, and how safety or efficacy data will affect the commercial outlook for medicines, devices, and diagnostics — think of it as the gut’s selective sponge and barrier.
stromal layer medical
"or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer."
A stromal layer is the supportive tissue that surrounds and holds together the working cells of an organ or lesion, made up of connective fibers, blood vessels and other non‑specialized cells. Think of it as the building’s scaffolding and plumbing that shapes, feeds and cushions the active rooms; changes to this layer can alter how diseases behave, how well drugs reach targets, or how medical devices integrate, so investors watch stromal effects as they can affect treatment success and market value.
antibody-drug conjugates medical
"NAMkind™ intestine models were also tested with antibody-drug conjugates (ADCs)"
A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.
permeability endpoints medical
"Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload."
Permeability endpoints are the measurable results that show how well a drug or molecule can pass through biological barriers (like the gut lining, blood vessels, or the blood–brain barrier) to reach its target. They matter to investors because these results help predict whether a therapy can work in patients and what safety or dosing challenges may arise—think of them as test results that reveal whether a delivery route is open or blocked, which affects development risk and potential value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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VivoSim’s NAMkind™ Intestinal Model combined with AI prediction tools yields high-accuracy results

SAN DIEGO, April 28, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced the availability of an AI prediction tool leveraging its NAMkind™ intestinal models to accurately predict the potential of a given drug compound to cause diarrhea in patients. The tool integrates its proprietary NAMkind™ ileum and colon tissues with advanced machine‑learning analytics to identify drug‑induced disruptions to intestinal epithelial integrity and function. Tissue-based assay data is used to train an AI predictive model in a process VivoSim has named VitroSense™.

The model was built using a training set of dozens of compounds. Using high-quality real-world 3d NAM assay results generated from the set of training compounds, the model attained a predictive accuracy of 96% for potential diarrhea. This success represents a significant step forward for the field, demonstrating the value of combining data from VivoSim’s complex 3D cell-based assays with machine learning approaches. For a novel compound being investigated for the first time, such as from a client, multiple data endpoints are measured in NAMkind™ intestine assays and these data are fed into the AI prediction model to generate an overall assessment of diarrhea risk. Because so many cancer drugs have dose-limiting toxicities, the Company believes that this breakthrough over reliance on animal models can have a transformational impact on the next generation of cancer treatments.

VitroSense™ – the use of NAMkind™-produced data to train predictive machine learning models

Central to the concept of use of NAMkind™ models in this way is its integration with its proprietary VitroSense™ toolkit that generates trained machine language models using data from its highly relevant human cell NAMkind™ tissues.

“The high biological fidelity of NAMkind™ models allows us to generate data in line with what is seen in humans” said Keith Murphy, VivoSim Executive Chairman. “By using that high-quality data to train AI models, we get much more accurate predictions. You’ve heard of “garbage in, garbage out”, but our models are the opposite: Golden raw data from NAMkind™ tissue assays is fed to the VitroSense™ model and spun into solid gold predictions for our clients’ compounds.”

NAMkind™ intestine models allow for mimicking oral or IV administration route, and are excellent for antibody drug conjugate testing.

Because of the advanced nature of the NAMkind™ intestinal model, the multilayered structure can be dosed either by mimicking oral administration or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer.

As recently demonstrated at Society of Toxicology, NAMkind™ intestine models were also tested with antibody-drug conjugates (ADCs) and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload.

“With 96% prediction accuracy, we believe our intestinal model is world class,” said Amar Sethi, Chief Scientific Officer of VivoSim. “It has the ability to weed out novel compounds with toxic liabilities from those compounds that would survive rigorous clinical trials.”

VivoSim is now working with clients to provide an effective screen for effects on the intestinal epithelium for oncology ADC candidates.

NAMKind™ liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.

About VivoSim Labs

VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding NAMKind™, including target turnaround time and its potential to help users de-risk their pipelines, avoid costly downstream failures, reduce rework, prioritize the right assets, move faster, save millions and reduce risk; VivoSim’s commercial presence across Asia-Pacific; the evaluation and acceptance of scientifically robust NAM-based evidence; the Company’s ability to capture growing demand in the in vitro toxicology testing market; demand for human-relevant toxicology; the market opportunity and market size of gastrointestinal in vitro models and toxicology services; and the Company’s scaling capacity to support expanding global demand and development needs. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 11, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. 

Contact(s):
Investor Relations
info@vivosim.ai
VivoSim Labs, Inc.


FAQ

What is VitroSense™ from VivoSim (VIVS) and what does it predict?

VitroSense™ is VivoSim's AI toolkit that predicts diarrhea risk from drug compounds. According to the company, it uses NAMkind™ ileum and colon 3D assay data to generate machine-learning predictions for intestinal toxicity.

How accurate is VivoSim's VitroSense™ diarrhea prediction model (VIVS) dated April 28, 2026?

VivoSim reports the VitroSense™ model achieved 96% predictive accuracy for potential diarrhea. According to the company, that accuracy comes from training on high-quality 3D NAM assay results from dozens of compounds.

Can VivoSim's NAMkind™ intestine models (VIVS) test antibody-drug conjugates (ADCs)?

Yes. According to the company, NAMkind™ intestine models detected differential ADC effects on epithelium, distinguishing antibody activity, payload impact, and combined ADC impact in assays.

Where are VivoSim's NAMkind™ liver and small intestine toxicology services (VIVS) available?

VivoSim offers NAMkind™ liver and small intestine services in the US and Europe and via local distributors in Korea and China, with ongoing capacity scaling, according to the company.